Resorbable, drug-eluting submucosal turbinate implant device and method

ABSTRACT

Implants are placed in turbinate mucosal tissue using a surgical device having a proximal grip portion and a distal hollow sharp needle portion that is manipulated using the grip portion and inserted submucosally into mucosal turbinate tissue. One or more biodegradable, drug-eluting solid implants are disposed within the needle. The implants have one or more implant withdrawal-discouraging, mucosal tissue-engaging surface features along their length. An actuator disposed within the device is used to deliver one or more of the implants from the needle into the mucosal turbinate tissue and submucosally bury at least one such tissue-engaging feature therein.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/836,594, filed Aug. 26, 2015, the contents of which is incorporatedby reference herein.

TECHNICAL FIELD

This invention relates to the treatment of sinus conditions includinginflammation of the turbinates.

BACKGROUND

The turbinates are soft mucosal tissue ridges which are supported bybony understructure, project into the nasal passages, and help warm andmoisturize air flowing through the nose. Swollen or otherwise enlargedturbinates can inhibit or obstruct breathing. Treatment therapiesinclude topical or oral administration of nasal decongestants, steroids,anti-inflammatories or other medicaments, and in some instances the useof surgery to remove, reduce or resection the swollen mucosal orsupporting bone tissue.

A variety of drug-eluting biodegradable or non-biodegradable deviceshave been proposed for insertion into nasal passages and sinus cavities.Typically these devices are exposed to air within the nasal or sinuscavity, and in some instances a suture or other fastener is used toretain the device in place.

SUMMARY OF THE INVENTION

The turbinates are exposed to air and fluids, may vibrate or otherwisemove during normal breathing, sneezing or nose blowing, and employ ciliaand other natural defenses to remove foreign matter and other debris.These factors may dislodge or help dislodge a drug eluting device.Although drug eluting devices may be placed and retained using sutures,doing so represents an extra step and may cause added trauma.

The invention provides in one aspect a surgical device comprising:

-   -   (a) a proximal grip portion configured to be grasped outside a        patient;    -   (b) a distal hollow sharp needle portion configured to be        manipulated using the grip portion and inserted submucosally        into mucosal turbinate tissue in the patient;    -   (c) one or more biodegradable, drug-eluting solid implants        disposed within the hollow needle portion, the implants having a        length along the hollow needle portion, and one or more implant        withdrawal-discouraging, mucosal tissue-engaging surface        features along such length; and    -   (d) an actuator disposed within the device and configured to        deliver one or more of the implants from the hollow needle        portion into such mucosal turbinate tissue and submucosally bury        at least one such tissue-engaging feature therein.

The invention provides, in another aspect, a method for sinus treatment,the method comprising providing a surgical device comprising:

-   -   (a) a proximal grip portion configured to be grasped outside a        patient;    -   (b) a distal hollow sharp needle portion configured to be        manipulated using the grip portion and inserted submucosally        into mucosal turbinate tissue in the patient;    -   (c) one or more biodegradable, drug-eluting solid implants        disposed within the hollow needle portion, the implants having a        length along the hollow needle portion, and one or more implant        withdrawal-discouraging, mucosal tissue-engaging surface        features along such length; and    -   (d) an actuator disposed within the device and configured to        deliver one or more of the implants from the hollow needle        portion into such mucosal turbinate tissue and submucosally bury        at least one such tissue-engaging feature therein;        manipulating the grip portion to pierce such mucosal turbinate        tissue and submucosally insert the hollow needle portion        therein, and activating the actuator to deliver one or more of        the implants from the hollow needle portion into such soft        tissue and submucosally bury at least one such tissue-engaging        feature within such tissue.

BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a schematic view of the turbinates;

FIG. 2 is an exploded view of a surgical device for implanting thedisclosed drug-eluting implants into mucosal turbinate tissue;

FIG. 3 is a cross-sectional view of the distal needle end of the FIG. 2device inserted into turbinate tissue and with a plurality of thedisclosed drug-eluting implants disposed therein; and

FIGS. 4A through 4K are side sectional views of exemplary drug-elutingimplants with a variety of implant withdrawal-discouraging, mucosaltissue-engaging surface features.

Like reference symbols in the various figures of the drawing indicatelike elements. The elements in the drawing are not to scale.

DETAILED DESCRIPTION

The following detailed description discusses certain embodiments and isnot to be taken in a limiting sense. All weights, amounts and ratiosherein are by weight, unless otherwise specifically noted.

FIG. 1 shows a schematic view of the nasal and sinus passages in humanpatient 1. Eyes 4 and nostrils 6 are included in the view to assist invisualizing the location and size of maxillary sinuses 8 and nearbyturbinates 10, 20, 30, 40, 50 and 60. Superior turbinate 10, middleturbinate 20 and inferior turbinate 30 are located on the left side ofFIG. 1, and right of the patient midline from the perspective of patient1, and are in a normal, unswollen condition. Superior turbinate 40,middle turbinate 50 and inferior turbinate 60 are located on the rightside of FIG. 1, and left of the midline from the perspective of patient1, and are each in an abnormal, swollen condition such as may interferewith normal breathing. In an adult human patient with chronicrhinosinusitis (CRS), the turbinates may for example be swollensufficiently so as to have a thickness of about 1 cm and a length of 3-4cm. In pediatric human patients with CRS the corresponding dimensionsmay for example be a thickness of about 0.5 cm and a length of about 2-3cm. The disclosed surgical devices may for example be sized to fitsubmucosally within such swollen tissue.

Referring to FIG. 2 and FIG. 3, exemplary surgical device 100 mayconveniently be made from an injection-molded sterilization-resistantthermoplastic co-molded with a metal needle portion discussed in moredetail below. Exemplary thermoplastics include ABS, nylon,polycarbonate, polystyrene and other materials that will be familiar topersons having ordinary skill in the art. Device 100 includes a proximalpistol-grip portion 202 shaped and sized to be received within thegloved palm of a physician. A plurality of optional ribs 204 in handle202 facilitate uniform distribution of plastic in the molding processand provide an improved gripping surface. Handle 202 is also shaped andsized so that the physician's thumb can readily apply force towards boreopening 208 in barrel 210. Barrel 210 extends from handle 202 andconnects with a needle retention and alignment portion 212 whichterminates at a distal end 214. Portion 212 may be curved or otherwisebent as shown in FIG. 1 or may have other shapes (e.g., straight) tofacilitate manipulation of distal end 214 into position near a targetsite on a turbinate. Hollow needle 216 projects from distal end 214 andincludes a sharp distal tip 218 that can be used to pierce mucosalturbinate tissue. Needle 216 may be straight as shown in FIG. 1 or mayhave other shapes (e.g., curved or otherwise bent) to facilitateinsertion of tip 218 into mucosal turbinate tissue. Optional depth ofinsertion marks 220, 222 and 224 provide an indicator for judging theextent to which needle 216 has been inserted into tissue.

The length and shape of needle retention and alignment portion 212 andneedle 216 may be selected so that device 100 is optimally used toaccess only one turbinate (e.g., a superior, middle or inferiorturbinate) or so that device 100 may be used to access more than oneturbinate (e.g., a superior and middle turbinate, a middle and inferiorturbinate, or each of a superior, middle and inferior turbinate). Device100 may also be made in a variety of shapes and sizes, e.g., for humanadult, human pediatric or veterinary (e.g., bovine, equine, ovine,porcine, canine or feline) use. Exemplary lengths for needle 216(including both the visible or exposed portion or needle 216 as well asportion 216a extending into portion 212) may for example be about 5 toabout 10 cm for human adult use, about 3 to about 8 cm for humanpediatric use, and shorter, similar or longer lengths for veterinary usedepending on the chosen animal. The exposed portion of needle 216 mayfor example have a length of about 2 to about 5 cm or about 2 to about 4cm for human adult use, about 1 to about 3 cm or about 1 to about 2 cmfor human pediatric use, and shorter, similar or longer lengths forveterinary use. Needle 216 may for example have an outer diameter ofabout 0.23 mm to about 4.6 mm or about 0.23 mm to about 1.7 mm, and aninner diameter of about 0.1 mm to about 3.8 mm or about 0.1 mm to about1.2 mm, corresponding approximately to Needle Wire Gauge values of 32gauge to 7 gauge or 32 gauge to 16 gauge.

In the embodiment shown in FIG. 2, barrel 210 includes three openings226, 228 and 230 along the left side of barrel 210 as viewed by thephysician and spaced along its axial dimension, and three optionalsimilar opposing openings (not shown in FIG. 2) on the right side ofbarrel 210 as viewed by the physician. The FIG. 2 device may be suppliedwith one or two similar or different implants 232 a and 232 b shownoutside needle 216 in the FIG. 2 exploded view, and shown axiallystacked end-to-end inside needle 216 in the FIG. 3 cross-sectional view.Implants 232 a and 232 b have one or more implantwithdrawal-discouraging, mucosal tissue-engaging surface features alongtheir length as is discussed in more detail below. A protective cap 234may be included with device 100 to cover tip 218.

As will be appreciated by persons having ordinary skill in the art, theembodiment shown in FIG. 2 and FIG. 3 may be modified so as to besupplied to a physician with any desired number of implants, e.g., withthree or more implants located axially inside needle 216. The spacingbetween openings 226 and 228 desirably corresponds to the axial lengthof implant 232 a, and the spacing between openings 228 and 230 desirablycorresponds to the axial length of implant 232 b. For the embodimentshown in FIG. 2 and FIG. 3, the axial lengths of implants 232 a and 232b, the space between openings 226 and 228, and the space betweenopenings 228 and 230 are all the same, but need not be so. Openings 226,228 and 230 cooperate with slider mechanism 300 to provide one or moreand preferably each of visual, audible and tactile feedback to aphysician of the progress of an implant or implants through needle 216as is discussed in more detail below.

Slider mechanism 300 has a generally cylindrical body 302 sized to beslidably received within bore 208. Body 302 includes a proximal thumbtab 304 positioned to be engaged by the thumb of the physician grippinghandle 202. Flexible pin 306 extends axially and distally from thedistal end of body 302 and is sized to pass through a corresponding boreopening 308 in portion 212, shown in phantom in FIG. 2. One or moreflexible lever arms 310 (two are shown in the FIG. 2 embodiment) projectlaterally and rearwardly from pin 306 and terminate at a latch orlatches 312. Locating tab 314, and an optional further locating tab (notshown in FIG. 2) that may be located for example on the right side ofslider mechanism 300, project laterally and outwardly from body 302.Latch or latches 312 and tab or tabs 314 are sized to be slidablyreceived by interior recessed slot or slots 316 axially located alongthe sides of barrel 210. Latch or latches 312 are also sized to expandinto and engage openings 226, 228 and 230 and the optional similaropenings on the right side of barrel 210 as body 302 travels throughbore 208 of barrel 210. Latch or latches 312 are shaped and sized topermit insertion of body 302 into bore 208 and distal advancement ofbody 302 via thumb pressure on thumb tab 304. When so advanced, body 302can move from a position in which a latch 312 is engaged in opening 226to a position in which such latch 312 becomes engaged in opening 228, orfrom a position in which a latch 312 is engaged in opening 228 to aposition in which such latch 312 becomes engaged opening 230. Latch orlatches 312 are also shaped and sized so that once a latched positionhas been reached at openings 226, 228 or 230, body 302 cannot beproximally withdrawn from bore 208 unless latch or latches 312 arepressed inwardly before pulling body 302 from bore 208.

As supplied to the physician, body 302 desirably is already insertedinto bore 208 so that latch or latches 312 and tab or tabs 314 ridewithin recess or recesses 316. Body 302 also desirably is advancedsufficiently far into bore 208 so that the distal end of pin 306contacts the proximal end of the nearest implant. For example, when onlyone implant like implant 232 a will be provided in device 100, then thedistal end of pin 306 may contact the proximal end of such implant. Whenas is shown in FIG. 3 two implants like implants 232 a and 232 b areprovided in device 100, then the proximal end 307 of pin 306 may contactthe proximal end 233 of the most rearwardly-located implant 232 b. Latch312 desirably engages opening 228 when only one implant is provided indevice 100 as supplied to the physician, and desirably engages opening226 when two implants are provided in device 100 as supplied to thephysician. Similar engagement desirably is present if theabove-mentioned optional right side latches and openings are employed. Aremovable lockplate 320 may also be provided in device 100 to block orotherwise prevent or limit accidental advancement of body 302 intobarrel 210 until such time as the physician is ready to use device 100.

Device 100 normally will be provided to the physician in sterilepackaging such as a sealed and suitably irradiated vial, pouch, bag, boxor tray. When the time comes for a physician to use device 100 in asurgical procedure, device 100 is removed from such packaging, cover 234and lock 320 are removed if present, needle 216 and portion 212 areinserted into one of the nares and grip 202 is manipulated so thatneedle 216 pierces the desired turbinate mucosal tissue target area. Forexample, FIG. 3 shows needle 216 partially inserted into turbinatetissue 330, at an insertion depth of about one-half the length ofimplant 232 a. Insertion guides 220, 222 and 224 may be employed tojudge how deeply tip 218 should be inserted submucosally so as toprovide a desired depth of implant insertion. When the desired depth isreached, the physician may press thumb tab 304 towards the distal end ofdevice 100, causing latch 312 to vacate its current opening 226 or 228and travel axially towards the next opening 228 or 230, and causing thedistal end of pin 306 to force implant 232 a or 232 b through needle 216and out of needle tip 218 so as to bury submucosally at least a portioncontaining a tissue-engaging feature, and more preferably a majority andmost preferably all of the length such implant, into the targetturbinate mucosal tissue. Upon departure of latch 312 from its currentopening 226 or 228, the physician will receive visual, audible ortactile indication that implantation of the distal end of the implantinto the tissue has commenced. Partial submucosal burying of the implantmay be carried out by inserting enough of the implant into the targettissue to submucosally bury at least one tissue-engaging feature thereinwhile holding needle 216 at a desired insertion depth less than thelength of the implant (e.g., at depth indicator 220 or 222), haltingpressure upon thumb tab 304 before latch 312 reaches the next opening228 or 230, and then withdrawing needle 216 from the target tissue sothat the implant remains behind and partially projects from the targetsite into the surrounding air-filled cavity. Complete submucosal buryingof an implant, or submucosal burying of more than one implant in asingle insertion site, may be carried out for example by insertingneedle 216 to a desired insertion depth (which may be but need not be adepth greater than the implant length), pressing thumb tab 304 untillatch 312 arrives at the next opening 228 or 230 while holding needle216 at the desired insertion depth, and then withdrawing needle 216 fromthe tissue so that the implant or implants remain behind, completelyburied, and entirely in contact with the surrounding turbinate tissue.The physician may be aided in doing so by the visual, audible or tactileindication provided by arrival of a latch or latches 312 at the nextopening 228 or 230, which indication will also signal that the proximalend of the implant has exited needle 216 via tip 218 and that pressureupon thumb tab 304 may be halted. If desired, such pressure may becontinued to further advance body 302 and cause another implant to exitneedle 216 and become wholly or partly buried in the target tissue site.

If only one or less than all the implants in the disclosed surgicaldevice have been used, device 100 may if desired be removed from thepatient and discarded. Alternatively, needle 216 may be moved to a newtarget site (e.g., from a superior turbinate to the middle turbinate orto another site on the initial target turbinate) so that any remainingimplant or implants may be submucosally buried at the new target site.Desirably however this is done while taking appropriate care to avoidmicrobial cross-contamination between target sites. Consequently thedisclosed device preferably is used to bury multiple implants withinonly a single turbinate.

The disclosed surgical device may be modified in a variety of ways. Inplace of the disclosed pistol grip device, other configurations such asa finger grip device or a power-assisted device may be employed.Endoscopic, luminescent, electromagnetic, magnetic, radiographic orother navigation aids may be added to the device to aid in positioningthe device and its needle tip. For example, a miniature light-emittingdiode may be added to distal end 214 and employed as an endoscopicillumination or external transillumination aid to help position needletip 218 near the desired target area. Lumens to provide features such asirrigation, suction, administration of local anesthetic or the removalof biopsy samples may also be added to the device. A larger-diametertrocar may be used in place of a smaller-diameter needle such as needle216. Magazines to facilitate loading additional implants may also beemployed if desired. Persons having ordinary skill in the art willappreciate that other modifications may be made if desired.

A variety of implants may be employed in the disclosed surgical device.Preferably, the implant includes a biodegradable matrix (for example, apolymeric matrix) with the drug dispersed therein or coated thereon. Thebiodegradation characteristics of the implant preferably are such thatit remains at the implantation site for at least three days, for atleast one week, or for at least two weeks. The biodegradationcharacteristics of the implant also preferably are such that the implantsubstantially disappears from the implantation site in less than abouttwo months, in less than about one month, or in less than about threeweeks. The drug elution characteristics of the implant preferably aresuch that the drug elutes from the implant for at least three days, forat least one week or for at least two weeks after implantation.

Exemplary matrix polymers include synthetic polymers such as polyesters(for example, polylactides such as polylactic acid or “PLA”,poly(lactide-co-glycolide) or “PLGA” copolymers, and cyclic esters suchas ϵ-caprolactone), polyanhydrides, polyorthoesters, polyalkyleneglycols (for example, polyethylene glycol or “PEG”), polycarbonates,polyamides, polyphosphoesters, polyphosphazenes and polycyanoacrylates,and natural polymers such as polysaccharides, proteins and nucleicacids. Polyalkylene glycols and PLGA copolymers represent a preferredform of synthetic polymer, and polysaccharides represent a preferredclass of natural polymer. Exemplary polysaccharides include agars,alginates, carrageenans, celluloses, chitins, chitosans, chondroitinsulfates, dextrans, galactomannans, glycogens, hyaluronic acids,starches, derivatives (including oxidized polysaccharides and salts) ofany of the foregoing, and mixtures of any of the foregoing. The matrixpolymer may be uncrosslinked or crosslinked. Additional matrix materialsare described in U.S. Patent Application Publication Nos. US2007/0014830 A1 (Tijsma et al.) and US 2007/0110788 A1 (Hissong et al.).The matrix may include colorants, radiopaque fillers or other additivesto aid in visualization or navigation.

A variety of drugs may be used in the disclosed implant. Preferred drugsare useful for the treatment of nasal and sinus conditions and includeangiotensin convertin enzyme (ACE) inhibitors; angiotensin receptorblockers (ARBS); antihistamines; steroidal or non-steroidalanti-inflammatory agents; chymase inhibitors; cyclooxygenase-2 (COX-2)inhibitors; decongestants; matrix metalloproteinase (MMP) inhibitors(e.g., doxycycline, TIMP metallopeptidase inhibitor 1 anddexamethasone); mucolytics; therapeutic polymers and combinationsthereof. Additional examples of these and other drug classes and drugsare listed in the above-mentioned Tijsma et al. and Hissong et al.applications. If desired, other therapeutic agents for the treatment orprevention of various conditions may be employed, including analgesics,anti-cholinergics, anti-fungal agents, anti-parasitic agents, antiviralagents, biostatic compositions, chemotherapeutic/antineoplastic agents,cytokines, hemostatic agents (e.g., thrombin), immunosuppressors,nucleic acids, peptides, proteins, vasoconstrictors, vitamins, mixturesthereof, and additional other therapeutic agents that will be familiarto persons having ordinary skill in the art. A useful list of such othertherapeutic agents may be found, for example, in U.S. Patent ApplicationPublication No. US 2007/0264310 A1 (Hissong et al.). The implant mayconsist of or consist essentially of the drug, or the drug and othertherapeutic agent, or may consist of or consist essentially of theabove-mentioned matrix and drug, or the matrix, drug and othertherapeutic agent. When a matrix is employed, the drug or drug and othertherapeutic agent may be impregnated into or dispersed within thematrix, or the surface of the matrix may be dip coated, spray coated,conjugated with or otherwise covered with or bound to the drug or thedrug and other therapeutic agent.

Exemplary lengths for the disclosed implants may for example be about 1mm to about 2 cm or about 1 mm to about 1 cm for human adult use, about1 mm to about 1 cm or about 1 mm to about 7 mm for human pediatric use,and about 1 mm to about 4 cm or about 1 mm to about 3 cm for veterinaryuse. Exemplary outer diameters for the disclosed implants may forexample be about 0.1 mm to about 3.8 mm or about 0.1 mm to about 1.2 mmfor human adult, human pediatric use or veterinary use.

FIG. 4A through FIG. 4K show several exemplary implants withwithdrawal-discouraging, mucosal tissue-engaging surface features. Suchfeatures may include projections (e.g., bumps, ribs, hooks or a ratchetrack), recesses (e.g., dimples, grooves or porosity), changes incross-sectional shape or changes in cross-sectional area along thelength of the implant. The implant may be symmetrical or asymmetricalabout a central longitudinal axis, they have a generally cylindrical ornon-cylindrical e.g. prismatic) shape with respect to such axis, and mayhave a blunt (e.g., flat), rounded (e.g., domed), sharpened (e.g.,pointed) or chiseled (e.g., wedge-shaped) proximal (insertion) end, anda similar or different distal end.

The implant may be rigid, or may be compressible with no, slow or rapidrecovery of the shape prior to compression. In one embodiment, thewithdrawal-discouraging, mucosal tissue-engaging surface features have aconfiguration such that the work (expressed as a product of force timesdistance) required to bury the implant submucosally in turbinate tissueis less than the work required to remove the buried implant from suchtissue. In another embodiment, the withdrawal-discouraging, mucosaltissue-engaging surface features have a configuration such that themaximum force required to bury the implant submucosally in turbinatetissue is less than the maximum force required to remove the buriedimplant from such tissue. Preferably at least a majority of implantvolume and more preferably all of the implant volume is buried in andcontacts turbinate tissue after implantation. In one embodiment, theimplant is not tensioned after implantation. In another embodiment, theimplant does not draw tissue together after implantation. In yet anotherembodiment, the implant is not injected into or through and does notcontact bone.

FIG. 4A is a cross-sectional view of implant 402 whose centralconstricted region 403 has a withdrawal-discouraging stop surface 404near domed distal (insertion) end surface 406 and a gradual taperedsurface 408 near proximal (trailing) end surface 409. Implant 402preferably is made from a relatively stiff biodegradable matrix thatwill penetrate and laterally displace turbinate tissue when injectedtherein. After implant 402 has been submucosally buried, nearbydisplaced tissue preferably returns to the constricted region 403 toprovide a tissue-engagement surface adjacent stop surface 404.

FIG. 4B is a cross-sectional view of implant 410 having a plurality ofoutwardly-projecting bumps 412 arrayed around the otherwise generallycylindrical surface 414 of implant 410. Bumps 412 provide awithdrawal-discouraging, mucosal tissue-engaging surface feature.Implant 410 may if desired employ a less stiff biodegradable matrix thanthe matrix used for implant 402, as the design of implant 410 has asubstantial minimum diameter and consequently may have better inherentresistance to bending than will be the case for implant 402. The endsurfaces of implant 410 may if desired be symmetrical so that either endmay serve as the distal (insertion) end surface.

FIG. 4C is a side sectional view of implant 420 having a plurality ofoutwardly-projecting circumferential ribs 422 arrayed around and alongthe length of the otherwise generally cylindrical surface 424 of implant420. FIG. 4D is a cross-sectional view of implant 430 having a pluralityof inwardly-directed grooves 432 arrayed around and along the length ofthe otherwise generally cylindrical surface 434 of implant 430. Both theribs 422 and grooves 432 provide withdrawal-discouraging, mucosaltissue-engaging surface features.

FIG. 4D is a cross-sectional view of implant 440 having a row ofoutwardly-projecting asymmetric latches formed by stops 442 and ramps444 arrayed along the side of implant 440 between distal end surface 446and proximal end surface 448. The stops 442 and ramps 444 providewithdrawal-discouraging, mucosal tissue-engaging surface features, andare analogous to the ratchet rack in a so-called “zip tie” fastener.

FIG. 4F is a side sectional view of implant 450 having a braidedstructure formed by fibers such as fibers 452 and 454. Both the exposedouter portion of the fibers and the small depressions such as depression456 formed where fibers overlap provide withdrawal-discouraging, mucosaltissue-engaging surface features.

FIG. 4G and FIG. 411 show cross-sectional views of a swellable implant460 which may as shown in FIG. 4G be generally cylindrical or prismaticprior to injection. As shown in FIG. 411, after implant 460 has beeninjected below the surface of turbinate tissue 468, contact with fluids(e.g., water, mucus or blood) present in or near tissue 468 causesimplant 460 to become swollen. The resulting increase in implantdiameter provides a withdrawal-discouraging, mucosal tissue-engagingsurface feature.

FIG. 4I is a cross-sectional view of a resilient, compressible implant470 having a reduced diameter when constrained inside needle 216. Wheninjected into turbinate tissue 478 , implant 470 expands while incontact with such tissue and assumes its normal unrestrained shape withan expanded diameter. The resulting expanded diameter provides awithdrawal-discouraging, mucosal tissue-engaging surface feature.

FIG. 4J is a side sectional view of a helical implant 480 that with theaid of a suitable rotating insertion device can be screwed intoturbinate tissue. Implant 480 preferably is made from a very stiffbiodegradable matrix that can withstand the associated insertion forces.

FIG. 4K is a cross-sectional view of a generally curved implant 490lodged in turbinate tissue 498. Implant 490 may be inserted into suchtissue with the aid of a suitably curved insertion needle. If implant490 has sufficient resiliency and shape memory, it may also be insertedusing a straight insertion needle and allowed to assume a curved shapeafter it exits the needle tip. The curved shape provides awithdrawal-discouraging, mucosal tissue-engaging surface feature.

The complete disclosure of all cited patents, patent applications,technical bulletins and other publications are incorporated herein byreference as if individually incorporated.

Although specific and in some cases preferred embodiments have beenillustrated and described, it will be appreciated by those of ordinaryskill in the art that a variety of alternate or equivalent embodimentscalculated to achieve the same purposes may be substituted for thespecific embodiments shown and described above. This application isintended to cover any such adaptations or variations of the embodimentsdiscussed herein. Therefore, it is manifestly intended that thisinvention be limited only by the claims and the equivalents thereof.

1-23. (canceled)
 24. A method for sinus treatment, comprising: graspinga proximal grip portion of a surgical device outside of a patient;manipulating the proximal grip portion to pierce mucosal turbinatetissue of the patient with a distal hollow sharp needle portion of thesurgical device and submucosally insert the distal hollow sharp needleportion into the mucosal turbinate tissue; and activating an actuatordisposed within the surgical device to deliver one or morebiodegradable, drug-eluting solid implants from the distal hollow sharpneedle portion into the mucosal turbinate tissue and submucosally buryat least one implant withdrawal-discouraging, mucosal tissue-engagingsurface feature along a length of each of the one or more implantswithin the mucosal turbinate tissue.
 25. The method of claim 24, whereindelivering one or more biodegradable, drug-eluting solid implants fromthe distal hollow sharp needle portion into the mucosal turbinate tissueincludes delivering two or more biodegradable, drug-eluting solidimplants into the mucosal turbinate tissue.
 26. The method of claim 24,further comprising receiving visible, audible or tactile feedback of theprogress of the one or more implants through the distal hollow sharpneedle portion via one or more tabs and openings of the surgical device.27. The method of claim 24, wherein the surgical device has one or morelatches that prevent removal of the actuator.
 28. The method of claim24, wherein the needle portion is bent.
 29. The method of claim 24,further comprising removing the surgical device from sterile packaging.30. The method of claim 24, wherein the one or more implants comprise apolymeric matrix with a drug impregnated or dispersed therein or coatedthereon.
 31. The method of claim 24, wherein the one or more implantsdegrade in less than one month in mucosal turbinate tissue.
 32. Themethod of claim 24, wherein the drug elutes from the one or moreimplants for at least three days and for less than one month.
 33. Themethod of claim 24, wherein the drug comprises an angiotensin convertinenzyme (ACE) inhibitor; angiotensin receptor blocker (ARBS);antihistamine; steroidal or non-steroidal anti-inflammatory agent;chymase inhibitor; cyclooxygenase-2 (COX-2) inhibitor; decongestant;matrix metalloproteinase (MMP) inhibitor; mucolytic; therapeutic polymeror combination thereof.
 34. The method of claim 24, wherein the drugcomprises doxycycline, TIMP metallopeptidase inhibitor 1 ordexamethasone.
 35. The method of claim 24, wherein the one or moreimplant withdrawal-discouraging, mucosal tissue-engaging surfacefeatures include projections.
 36. The method of claim 35, wherein theprojections comprise bumps, ribs, hooks or a ratchet rack.
 37. Themethod of claim 24, wherein the one or more implantwithdrawal-discouraging, mucosal tissue-engaging surface featuresinclude recesses.
 38. The method of claim 37, wherein the recessescomprise dimples, grooves or porosity.
 39. The method of claim 24,wherein the one or more implant withdrawal-discouraging, mucosaltissue-engaging surface features include a braided structure.
 40. Themethod of claim 24, wherein one or more implant withdrawal-discouraging,mucosal tissue-engaging surface features are swellable upon exposure tofluid.
 41. The method of claim 24, further comprising not tensioning theone or more implants after implantation.
 42. The method of claim 24,wherein the one or more implants do not draw tissue together afterimplantation.
 43. The method of claim 24, further comprising insertingthe one or more implants such that the one or more implants do notcontact bone after implantation.
 44. The method of claim 24, wherein thework, expressed as a product of force times distance, required to burythe one or more implants submucosally in the mucosal turbinate tissue isless than the work required to remove the one or more buried implantsfrom the mucosal turbinate tissue.
 45. The method of claim 24, whereinthe maximum force required to bury the one or more implants submucosallyin the mucosal turbinate tissue is less than the maximum force requiredto remove the one or more buried implants from the mucosal turbinatetissue.